Training and consulting in the areas of
- Medical device development for the European market
- DGUV V3 (in the area of medical devices) / DIN EN 62353 / VDE 0751-
- Electrical Device Development according to IEC 60601-1 / IEC 62304 / IEC 82304
- Technical documentation for medical devices
- Risk Management according to ISO 14971
- Usability according to IEC 62366-1
- ISO 13485 and (EU) 2017/745 / MDR
- Software as a Medical Device (SaMD)
- PMS and PMCF
- Medizinprodukte-Betreiberverordnung – MPBetreibV